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NCT Number: NCT07210944

Scalp Acupuncture Combined With rTMS for Upper Limb Motor Dysfunction in Stroke: A Brain Network Study

This study aims to compare the improvement effects of the rTMS (repetitive transcranial magnetic stimulation) combined with conventional rehabilitation therapy group with the rTMS combined with scalp acupuncture and conventional rehabilitation therapy group. Through statistical analysis of the results obtained from functional near-infrared spectroscopy technology during task states, the investigators elucidate the neuroregulatory mechanism of scalp acupuncture combined with rTMS in improving upper limb motor function in stroke patients under MEP localization, and provide evidence for a more optimal rehabilitation program for post-stroke upper limb motor dysfunction.

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Key information

Conditions

Upper Extremity Acupuncture Therapy Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Mental Disorders Motor Disorders Nervous System Diseases Stroke Transcranial Magnetic Stimulation Repetitive Vascular Diseases

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

the Third Affiliated Hospital of Zhejiang Chinese Medical University

Hangzhou, Zhejiang, 310000, China

Location contact

Debiao Kong

CONTACT

[email protected]

+8618334350769

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Meet the diagnostic criteria for stroke (symptoms and signs, imaging indicators, etc.), and are independently diagnosed by two deputy chief physicians
  • Age 18-70 years old, first episode, duration 1-6 months
  • The diagnostic criteria for upper limb dysfunction align with the Brunnstrom staging system: patients in Brunnstrom stages II to IV. Stage II: patients exhibit associative responses and can perform coordinated movements, with minimal voluntary movements; Stage III: patients show voluntary coordinated movements, such as grasping with the hand but not extending; Stage IV: patients can perform isolated movements, such as pinching with the hand and limited extension
  • No severe visual or hearing impairment, able to cooperate with relevant assessments and tests
  • The score of the Mini-Mental State Examination is ≥20 points
  • Vital signs are stable, with no signs of progressive neurological symptoms
  • The patient or legal guardian agrees and signs the informed consent form

Exclusion criteria

  • Severe visual impairment, hemispatial neglect, body image disorder
  • Individuals who cannot undergo rTMS treatment due to reasons such as metal implants, cardiac pacemakers, or skull defects
  • Previous history of brain tumor, brain trauma, epilepsy, and risk of epileptic seizures
  • Any other factors that affect assessment and treatment
  • Dysfunction of limb movement caused by other reasons (such as trauma, etc.)

Treatment and study plan

repetitive transcranial magnetic stimulation

Device

Transcranial magnetic stimulation applied a figure-8 coil to the premotor area at 80%-100% of the healthy-side MEP threshold. Treatment lasted 20 min in two phases: weeks 1-2 on the ipsilateral M1 (1Hz, 10s on/5s off), and weeks 3-4 on the contralateral M1 (10Hz, 3s on/12s off). Treat once a day, 5 days a week, for a total of 4 weeks.

Scalp acupuncture

Procedure

Scalp acupuncture selected bilateral upper-limb cortical MEP points (2 points total). The healthy-side hot spot was identified first; if the affected side had no MEP, its mirror point was used. Needles were inserted from point A (affected) to B (healthy) and beyond along the AB line. After insertion, needles were rotated for 2-3 min, manipulated every 10 min, and retained for 30 min. Treat once a day, 5 days a week, for a total of 4 weeks.

Conventional rehabilitation treatment

Combination Product

Conventional drug therapy included secondary stroke prevention, neurotrophy, and improved cerebral circulation. Routine rehabilitation involved exercise, occupational, and physical therapies, with a total daily treatment time of 90 minutes.

Primary outcomes

  1. Maximum amplitude of motor evoked potential

    Time frame: One day before treatment, four weeks after treatment

    It refers to the potential difference between the peak and trough of the motor evoked potential, reflecting the excitability of the cerebral cortex and neural pathways. It is detected using an RD-CCY type TMS stimulator in conjunction with a Viking Quest 4-channel surface electromyography recorder from the American company Neuropad.

  2. Fugl-Meyer Assessment-Upper Extremities

    Time frame: One day before treatment, four weeks after treatment

    It is a widely used standardized assessment tool in the rehabilitation of upper limb motor dysfunction after stroke. The FMA divides upper limb motor function into multiple dimensions, including reflex activity, coordinated movement, isolated movement, wrist and hand function, through systematic scoring items. A total of 33 items are included. Each item is scored on a 3-point scale (0-2 points), with a total score of 66 (upper limb part). Higher scores indicate better recovery of upper limb motor function.

Secondary outcomes

  1. Action Research Arm Test

    Time frame: One day before treatment, four weeks after treatment

    It includes 4 parts: grasping, holding, pinching, and gross motor function, with a total of 19 items. Each item is scored on a 4-point scale (0-3 points), with a total of 57 points. The higher the score, the better the recovery of upper limb motor function.

  2. Modified Barthel Index

    Time frame: One day before treatment, four weeks after treatment

    It is used to assess patients' ability to perform activities of daily living. It includes 10 items: eating, dressing, using the toilet, defecating, urinating, grooming, bathing, climbing stairs, transferring, and walking. The total score ranges from 0 to 100, with higher scores indicating better ability to perform activities of daily living. A score of >60 indicates that the patient can live independently.

  3. Functional near-infrared spectroscopy

    Time frame: One day before treatment, two weeks after treatment, four weeks after treatment

    Data were collected using a 35-channel fNIRS imaging device, NirSmart (HuiChuang, China), during resting state and scalp acupuncture stimulation. The device includes 17 light source probes and 14 detection probes, forming 35 effective channels in the experimental design, covering the forehead, bilateral frontal lobes, and motor areas. Continuous wave, near-infrared wavelength (760-850nm) signals were used with a sampling frequency of 11Hz, allowing real-time and effective monitoring of changes in the concentration of oxyhemoglobin and deoxyhemoglobin in the healthy side of the subject's brain. Based on coordinate information, the 35 channels were divided into five regions of interest in the left and right cerebral cortexes of the subject, namely the bilateral motor area, bilateral temporal lobe and forehead.

Study contacts

Contact information is provided by the study sponsor or research team.

Debiao Kong

CONTACT

[email protected]

+8618334350769

Sponsors and collaborators

Lead sponsor

Debiao Kong

Other

Registry information

Official study title

Research Protocol for a Randomized Controlled Trial on Brain Network Study of Upper Limb Motor Dysfunction in Stroke Patients Treated With Scalp Acupuncture Combined With rTMS

Important dates

Study start
2025
Primary completion
2026
Study completion
2027
First posted
Oct 7, 2025
Registry last updated
Nov 19, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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